Experimental Inflammation MedDRA version: 17.1 Level: PT Classification code 10057480 Term: Hyperbaric oxygen therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male volunteers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Lack of ability to equalize pressure in the inner ear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of hyperbaric oxygen on experimental inflammation in a blinded study;Secondary Objective: Pain reduction;Primary end point(s): Preconditioning and a reduction in secondary hyperalgesia.;Timepoint(s) of evaluation of this end point: After completing statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain reduction;Timepoint(s) of evaluation of this end point: After completing statistical analysis. | — |
Countries
Denmark
Contacts
Hyperbaric Unit, Department of Anaesthesiology, Dept. 4231, Rigshospitalet